Access to cancer drugs - Is our current system broken? (#16)
Background: The off-label use of a drug refers to a use outside the terms of its approval by the Therapeutic Goods Administration (TGA). It is also possible to prescribe unlicensed drugs under the TGA’s special access scheme. A high rate of off-label prescribing has previously been reported in cancer. There is a disparity between clinical evidence-based guidelines for anticancer therapy, product approval and funding status of these agents, as shown by our study conducted within an academic tertiary/quaternary cancer centre.
Method: All chemotherapy protocols approved for use in our oncology centre were assessed to determine if the drugs were off-label or unlicensed for that indication based upon review of their current product information. The Pharmaceutical Benefits Scheme (PBS) funding status for each protocol was subsequently assessed.
Results: A total of 448 protocols containing 82 different drugs across 15 tumour groups were identified. Overall, 189 (42.2%) of protocols were off-label, and three (0.7%) were unlicensed. This resulted in all 192 protocols being unfunded by the PBS. Of the 189 off-label protocols, 132 (69.9%) were based on established evidence-based treatment guidelines, and a further 39 (20.6%) were based upon phase II or III clinical trial data.
Discussion: Over 90% of off-label protocols are supported by established treatment guidelines or published peer-reviewed research even though the medications are not approved for that particular use by the TGA. However, these off-label protocols are unfunded by the PBS; this results in a marked inequality of access to appropriate medications for cancer patients across Australia.